Chlorpromazine Recall: Zydus Lifesciences lot Z403011, Z407335
Announced 2026-05-27 · FDA
The FDA is recalling Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count Rx bottles manufactured by Zydus Lifesciences Ltd. for Northstar Rx LLC, distributed nationwide in the United States, due to CGMP deviations with N-Nitroso Desmethyl Chlorpromazine above the acceptable intake limit. The affected lots are Z403011 (Exp 30-04-2026) and Z407335 (Exp 30-11-2026); NDC is 16714-047-01.
| Brand | Zydus Pharmaceuticals (USA) Inc |
|---|---|
| Product | Chlorpromazine Hydrochloride Tablets, USP, 10 mg, 100-count bottle, Rx only, Manufactured By: Zydus Lifesciences Ltd., Baddi, India; Manufactured for: Northstar Rx LLC Memphis, TN 38141. NDC: 16714-047-01 |
| Reason | CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit |
| Severity | moderate |
| Units affected | 10992 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | Lot#: Z403011, Exp Date 30-04-26; Z407335, Exp Date 30-11-26 |
WHAT YOU SHOULD DO
- If you have a bottle with Lot Z403011 or Z407335, stop using it immediately.
- Do not consume and contact your pharmacist or Northstar Rx LLC for instructions on disposal or replacement.
- Check with your healthcare provider if you have any health concerns or have used the product.
Other Zydus Pharmaceuticals (USA) Inc recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.